While radio frequency identification (RFID) and electronic product code (EPC) technology will be critical to assuring a safe pharmaceutical supply chain, the healthcare industry also has its eye on distribution and supply chain efficiencies.
Experts from the federal government and pharmaceutical industry who participated in the BIO 2005 annual meeting in Philadelphia June 22 focused a lot of attention on the benefits of using the technology to prevent fake drugs from entering the supply chain and getting to consumers.
In fact, Capt. Thomas J. McGinnis, representing the Food and Drug Administration (FDA), pointed out that counterfeit drug cases continue to increase as counterfeiters focus on finished dosage forms, high-cost and high-volume products. Well-funded counterfeiting networks are using sophisticated technologies for copying drugs, he said.
McGinnis also pointed out that FDA launched its Counterfeit Drug Initiative in July 2003 to prevent the introduction of counterfeit drugs, facilitate the identification of counterfeit drugs, minimize risk and exposure of consumers and avoid unnecessary costs to the drug distribution system.
The agency has identified RFID as the "cornerstone" in the battle against counterfeit drugs, and feels "widespread adoption of RFID" is feasible by 2007—contrary to some pharmaceutical companies that believe it will take as much as two years longer.
McGinnis said that adopting an "electronic pedigree" to electronically track and trace drug products from the manufacturer to the ultimate consumer will help to secure the movement of drugs through the supply chain. Other parts of FDA’s overall plan for thwarting counterfeit pharmaceuticals include:
Lisa Clowers, senior vice president of industry relations at the Healthcare Distributors Management Association (HDMA), moderated a panel of government and industry leaders on the benefits and challenges of using track and trace technology to secure the drug supply chain and create additional operational efficiencies.
"Supply chain integrity is a major focus area at HDMA," Clowers said, "and we continue to work with industry to implement anti-counterfeiting technologies such as EPC/RFID. As an industry, we cannot afford to waiver in our commitment to further protect the U.S. supply chain."
Clowers also emphasized the importance of the technology for supply chain efficiencies as well as:
Industry representatives, including Mike Rose, vice president, RFID/EPC global value chain, Johnson & Johnson; Ron Bone, senior vice president of distribution support, McKesson Pharmaceutical Supply; and John Cass, director of operations, AmerisourceBergen Corp., outlined efforts to further secure the integrity of the U.S. prescription drug supply chain.
Rose said secure electronic track and trace will help ensure that customers receive genuine products. He said mass serialization is an important mechanism to uniquely identify, track and trace products, adding that both barcodes and RFID should use the EPC as their serialization methodology.
"Cross supply chain collaboration is critical to successful EPC/RFID adoption," Rose said, providing for reliability, information visibility, security and privacy. He said there needs to be a uniform code across the United States and an industry-wide mechanism to authenticate products. More biotechnology company involvement is needed in the EPCglobal standard setting process, Rose said.
He added that the effects of RF on biologics need to be investigated, that consumers should be given notice whenever RFID is used, and the option to remove or disable tags when they are no longer needed. When all is said and done, Rose predicted RFID would provide:
Clearly, the pharmaceutical industry expects to enjoy many of the same logistical benefits of RFID as the food industry as adoption moves to the item level. But the stakes are obviously higher. They involve the safety of every consumer who can be harmed by counterfeit drugs or prescription mistakes, and food industry companies with pharmacy operations should pay attention to developments in that industry as they unfold. D